STA UNICALIBRATOR (ref. 00675) recallZ-0737-2020 · Diagnostica Stago, Inc. · initiated Nov 18, 2019

Why it was recalled

A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

FDA root cause category: Process control

What the company is doing

On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: FIELD SAFETY NOTICE Combined use of the following reagents STA UNICALIBRATOR (ref. 00675) and STA DEFICIENT VIII (ref. 00725) STA DEFICIENT IX (ref. 00724) Dear Customer, You are using the STA Unicalibrator (00675) and STA Deficient VIII (00725) and/or STA Deficient IX (00724) and according to our records, you have ordered and received in your laboratory one or several kits of the STA - Unicalibrator listed in Appendix 1. Following the identification of a defect, please see the information below about the reagents and lots listed in Appendix 1. Description: Following a customer complaint, Stago has investigated and confirmed a positive bias on some STA - Unicalibrator levels. These high levels affect tests using STA - Deficient IX and STA - Deficient VIII reagents. Stago has accordingly reduced the concerned Unicalibrator plasma levels (see new levels on the attached lot-specific barcode sheets). According to our internal testing results, the reduced Unicalibrator plasma levels result in a decrease of Factor VIII and IX results on normal and below-normal patient plasmas. This change has no impact on the classification of hemophiliac patients (type A or B) as severe, moderate or mild. The reassignment of the Unicalibrator plasma levels necessitated a change in the acceptance ranges on the corresponding Quality Control plasmas for Factor VIII and IX parameters with the STA - Deficient VIII and IX reagents. You will find new barcode sheets for each lot of the affected reagents in the attachments. Actions: Upon receipt of this letter, we kindly ask you to: - No longer use the values indicated for STA - Deficient VIII and IX reagents on the barcode sheets in your possession (for the reagents & lots listed in Appendix 1). - Use the new barcode sheets (attached): - For STA - Unicalibrator: Use the analyzer-spec

Recall details

Recall number

Z-0737-2020

Status

Terminated

Initiated by the company

Nov 18, 2019

Posted by the FDA

Dec 23, 2019

Recalling firm

Diagnostica Stago, Inc.

Quantity

5,498

Product code

GIZ

FDA submissions

K922021

Distribution

US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK

Product description

STA UNICALIBRATOR (ref. 00675)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• STA® - Unicalibrator 00675

  Diagnostica Stago · PLASMA, CONTROL, NORMAL
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 84402).

• Z-0738-2020 · Terminated
  STA SYSTEM CONROL N + P (ref. 00678)